Raw Oysters to Be Treated for Bacteria

November 8, 2009

Jacksonville

by Roger Bull

Before hunting, there was gathering.

Like an orange hanging on the tree, a raw oyster is one of the most basic of foods. Reach down and pull it out of the water, open it and eat it. OK, maybe add a little lemon or hot sauce.

But it may soon not be that simple. The U.S. Food and Drug Administration has decided that starting in 2011, raw oysters coming out of the Gulf of Mexico during warm-weather months must be treated before they can be sold to consumers.

They call it post-harvest-processing (PHP for short) and there are several methods – freezing, pressure, radiation – to kill vibrio vulnificus, a bacteria that occurs naturally in warm coastal waters and is more prevalent in the summer. But it can be fatal to people with liver disease, diabetes or other problems.

The bacteria causes about 30 people a year to get sick from eating raw gulf oysters and half of those die. And it’s the reason that warnings about eating raw seafood are printed on menus everywhere.

The FDA’s plan would apply only to oysters still in the shell because while shucked oysters sold in pints and gallons are still raw, it’s assumed they’ll be cooked before eaten. The FDA hasn’t been specific about what it considers warm-weather months, but discussions so far have indicated it would start in April or May and end in October.

That would loosely correspond to the old, unofficial tenet to eat oysters only in months with an “R.” And though oyster sales are better in cool months, 40 percent of oysters harvested in the gulf are during warm months.

The FDA would not talk to the Times-Union despite repeated requests, but the move has already drawn a storm of protest. Charles Bronson, Florida commissioner of agriculture, wrote a letter to the FDA on Wednesday objecting. On Thursday, Sens. Bill Nelson, D-Fla., Mary Landrieu, D-La., and David Vitter, R-La., announced a bill to stop the FDA’s plan.

But nowhere is the outrage greater than in Franklin County, the small Panhandle county where 90 percent of the state’s oysters are brought up by hand and tong from the bottom of Apalachicola Bay. More than 20 percent of the county’s 11,200 population work either in harvesting, shucking or shipping oysters.

“We’re all upset about it,” said Beverly Hewitt, owner of the Apalachicola Seafood Grill, a gathering spot at the center of the historic small town. “We had a emergency county commission meeting. This is going to kill Apalachicola.”

Tommy Ward, who runs Buddy Ward and Sons Seafood, the company his father started in Apalachicola in 1957, said it would cost him about $1 million to set up a PHP plant.

“We have to shut down in the summer,” he said. “It’d wipe out the whole county.”

Besides not being able to afford $1 million, Ward said that treated oysters simply don’t sell very well.

“They’re on the market now,” he said. “But the customers don’t accept them.”

Ahead of the curve

Grady Leavins, who’s been in the oyster business in Apalachicola for 38 years, is one of the few seafood dealers in the state who already treats oysters. His PHP plant freezes them at minus 130 degrees with liquid nitrogen and sells them on the half shell.

Sales are good, he said, and increasing. But they’re still only 5 to 7 percent of his total oyster sales, which are running about 400,000 pounds a week right now and will go up to 600,000 in another month.

Leavins sees himself as ahead of the curve.

“I knew that it was the thing that was going to be done,” he said. “Are we making money? Yes. Have we gotten our investment back? I don’t know, but anytime you do something like this, it’s a long-term thing.”

The treated oysters cost 2? to 3 times more than untreated and are sold to oyster bars and restaurants.

“They’re for the people who want a traditional oyster,” he said, “but have a compromised immune system.”

And that’s one of the things that bothers those in the oyster business the most: People should know when they should avoid the oysters.

“The biggest thing is cirrhosis of the liver from alcoholism,” Leavins said. “I’m a high-risk person; I’m a diabetic. So I don’t eat them in the summer.”

Click here for full report

FDA Says Mercury Dental Fillings Aren’t Harmful?!

July 28, 2009

Reuters

By Susan Heavey

WASHINGTON (Reuters) – The U.S. Food and Drug Administration said on Tuesday silver-colored dental fillings that contain mercury are safe for patients, reversing an earlier caution against their use in certain patients, including pregnant women and children.

“While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients,” the FDA said, citing an agency review of roughly 200 scientific studies.

Still, in final regulations issued on Tuesday as part of an earlier legal settlement, it said the fillings were now considered “moderate risk” devices and will include details about the risks and benefits of the products. They will also carry warnings against their use in patients with mercury allergies or in poorly ventilated areas.

Millions of Americans have such fillings to patch cavities in their teeth and the FDA said it does not recommend patients have them removed. The fillings, also known as amalgams, are a combination of other metals and mercury, which at certain levels has been linked to brain and kidney damage.

In 2006, Moms Against Mercury and three other groups sued the FDA to have mercury fillings removed from the U.S. market. Later that year, an FDA panel of outside experts said most people would not be harmed but that more information was needed.

Mercury — whether in dental, vaccines, fish or other products — has generated much controversy. Some consumer groups contend the fillings can trigger a range of health problems such as multiple sclerosis and Alzheimer’s disease.

Part of the problem is that while much is known about high exposures to heavy metals, questions remain about “what is happening at chronic low-level exposure over a lifetime,” said Urvashi Rangan, the director of technical policy for Consumer Reports, whose group was not part of the initial lawsuit.

But Susan Runner, acting director for the FDA division that oversees dental devices, said there was no “causal link” between amalgam fillings and health problems.

“The best available scientific evidence supports the conclusion that patients with dental amalgam fillings are not at risk,” she told reporters on a conference call.

Over the past 20 years, the agency has received just 141 reports of problems in patients with the fillings, she added.

That conclusion counters a statement the agency made last June that the fillings may cause health problems in pregnant women, children and fetuses.

The FDA’s decision could impact makers of metal fillings, which include Dentsply International Inc and Danaher Corp’s unit Kerr, as well as distributors such as Henry Schein Inc and Patterson Cos Inc.

Shares of Dentsply closed up than 21 cents at $30.80 on the Nasdaq while shares of Danaher closed down $1.18 at a $60.66 on the New York Stock Exchange. Shares of Henry Schein closed down 18 cents at $50.24 and Patterson closed up 4 cents at $24.41.

According to the American Dental Association (ADA), about 30 percent of fillings given to patients are mercury-filled, with a growing number of patients instead opting for lighter, tooth-colored options such as resin composites.

Alternative products include glass cement and porcelain as well as other metals such as gold, but they are more expensive. and considered less durable.

The ADA, which represents the dental industry, backed the FDA’s decision not to restrict mercury fillings, saying alternatives are also considered “moderate risk” by the FDA.

“The FDA has left the decision about dental treatment right where it needs to be — between the dentist and the patient,” ADA President Dr. John Findley said in a statement.

But Charlie Brown, a lawyer for Consumers for Dental Choice, said poorer people or those who receive their health care through large institutions such as the U.S. military are more likely to receive the cheaper, silver-colored fillings and are at greater risk for harm.

“Most consumers, and most dentists, have already switched to the main alternative, resin composite,” said Brown, whose group was part of the lawsuit settlement last June that called on the agency to issue more specific rules. His group is now weighing its legal options, he said.

Moms Against Mercury President Amy Carson said she was disappointed in the FDA’s reversal. Her group, along with several others, filed a new petition with the FDA on Tuesday, again calling for a ban on mercury fillings, she added.

Click here for the full report from Reuters.

Blood Thinner Effient Gets FDA Approval with Warning

The approval makes Lilly’s Effient the first real competition to the blood thinner Plavix, the world’s second-best selling medication made by Sanofi-Aventis and Bristol-Myers Squibb.

The FDA delayed its decision on Effient multiple times during an 18-month review, as agency staffers weighed the drug’s benefits versus its risks.

A study of over 13,000 patients conducted by Lilly found that Effient prevents more heart attacks than Plavix, but also causes more internal bleeding.

The FDA said Effient will carry a boxed warning to alert physicians to the risks of “significant, sometimes fatal, bleeding.” The boxed warning is reserved for issues that can cause serious injury or death.

The drug should not be taken by patients with a history of bleeding, stroke or who are undergoing surgery, the FDA said.

“Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug,” said Dr. John Jenkins, FDA’s director of new drugs.

The drug offers an alternative treatment for preventing dangerous blood clots that can lead to heart attack or stroke, Jenkins said. Company studies showed 7% of patients taking Effient experienced nonfatal heart attacks, compared with 9.1% of patients taking Plavix. Despite lower rates of certain heart attacks, the actual rates of death were similar for both drugs.

Indianapolis-based Lilly developed Effient, known chemically as prasugrel, with Japanese drugmaker Daiichi Sankyo Co. The two companies will share revenue.

“After more than a decade of research and testing, we are proud to provide this new treatment option to patients with acute coronary syndrome,” Daiichi President Takashi Shoda said in a statement.

Wall Street analysts say Effient sales could reach an estimated $1 billion annually, compared with the $4.9 billion racked up by Plavix last year.

Like Plavix, Effient prevents blood platelets from sticking together and forming potentially dangerous clots. But where Plavix is approved for use in a wide range of patients, Effient is only approved for those undergoing angioplasty, a common procedure in which an inflatable balloon is used to clear arteries clogged with plaque.

Approval of Effient was considered crucial for Lilly because patents protecting its four best-selling drugs expire by 2013.

But even if the drug reaches the $1 billion mark, it will have trouble replacing the revenue of Lilly’s best-selling product, the anti-psychotic Zyprexa, which garnered $4.7 billion in sales last year.

Click here for the full report from USA Today.

FDA Warns of Fatal Overdose Risk with Propoxyphene, but Leaves Narcotic on Pharmacy Shelves

July 8, 2009

ABC News

by Crystal Phend

The U.S. Food and Drug Administration has called for a boxed warning of overdose risk on packages of Darvon, Darvocet and other painkillers containing the drug propoxyphene — but it will not order their withdrawal from the market.

The agency ordered manufacturers to study higher-than-expected fatality rates in propoxyphene overdoses compared with other painkillers — and possible toxic effects on the heart in when consumers exceed recommended doses.

However, the FDA rejected a petition from the consumer group Public Citizen calling for phased withdrawal of these products.

In its action, announced during a press briefing on Tuesday, the agency rejected the advice of its own advisory panel, which voted 14-12 for a ban on propoxyphene products because of overdose risk and doubts about their painkilling effectiveness.

Propoxyphene is an opioid painkiller chemically similar to methadone. Some pain specialists, such as Dr. Lloyd Saberski of the Yale-New Haven Hospital in Connecticut, criticize propoxyphene as a weak narcotic with no place on the shelf.

“There is no legitimate medical advantage to keeping propoxyphene available,” Saberski said. “You are much better off using small amounts of a potent narcotic; there will be little in the way of side effects.”

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, defended propoxyphene as an effective combination treatment option that goes beyond the strength of acetaminophen — commonly known by the brand name Tylenol — alone.

“All current pharmacologic options for pain have significant liability,” she said in a media briefing. “Given the data currently available to FDA, propoxyphene is an acceptable choice for the treatment of mild to moderate pain when it’s taken as directed.”

Today’s announcement comes just a week after an FDA advisory panel recommended a black box warning for prescription products containing acetaminophen. That panel also voted by a narrow margin to recommend that the FDA pull prescription acetaminophen-containing analgesics from the market.

Click here for the full report from ABC News.

Black Box, Mixed Message? FDA Panel Delivers Acetaminophen Recommendations

July 1, 2009

ABC News

By Dan Childs & Emily Walker

If a U.S. Food and Drug Administration expert panel has its way, prescription pain killers, like Vicodin and Percocet that contain acetaminophen will be eliminated from the country’s formularies.

Yet, the very same panel voted to keep over-the-counter combination pills containing acetaminophen on the shelves.

Those recommendations are only two of 10 concerning acetaminophen the panel made, including one to lower the maximum dosage of over-the-counter pain medications that contain acetaminophen, like Tylenol.

A joint panel of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee voted on the issues after two days of considering ways to reduce the liver damage risk of acetaminophen, the most commonly used painkiller in the country.

The recommendations are not binding, but the FDA usually adopts them. It’s no clear when the FDA will announce a final decision.

The panel voted 24 to 13 against a proposal to remove over-the-counter combination drugs from the shelves. This would save drugs that combine acetaminophen and other drugs like caffeine like Excederin, and a wide variety of popular cough-and-cold combinations.

About 42,000 people visit emergency departments each year with acetaminophen overdoses, half of which are accidental. They often occur when a consumer unknowingly takes more than one acetaminophen product.

Doctors were largely split in their opinions over the votes — and the fault lines appeared to follow their areas of expertise and the kind of patients they treat.

Liver disease experts largely applauded the recommendations. Dr. William Lee, chair of the liver diseases department at the University of Texas Southwestern Medical Center at Dallas, said he was “highly gratified” by the outcome of the votes limiting acetaminophen use.

Click here to read the full ABC News report and to watch the video.

FDA Threatens to Seize All Natural Products that Dare to Mention H1N1 Swine Flu

June 18, 2009

NaturalNews.com

by Mike Adams

(NaturalNews) In an effort to censor any online text that might inform consumers of the ability of natural products to protect consumers from H1N1 influenza A, the FDA is now sending out a round of warning letters, threatening to “take enforcement action… such as seizure or injunction for violations of the FFDC Act without further notice.”

“Firms that fail to take correction action,” the FDA warns, “may also be referred to the FDA’s Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws.”

The message is crystal clear: No product may be described as protecting against or preventing H1N1 infections unless it is approved by the FDA. And which products has the FDA approved? Tamiflu (the anti-viral drug that most people will never have access to), and soon the new H1N1 vaccine that’s being manufactured at a cost of one billion dollars (paid to Big Pharma by the taxpayers). This vaccine, of course, will be utterly useless because H1N1 will undoubtedly mutate between now and the time the vaccine is ready, rendering the vaccine useless.

In other words, according to the tyrants at the FDA, the only products that may be marketed alongside the term “H1N1″ are those products that either don’t work or aren’t available to most people. Anything that really works to prevent influenza infections — such as natural anti-virals, medicinal herbs, etc. — is banned from even mentioning H1N1 without the threat of being criminally prosecuted.

Such are the operations of our U.S. Food and Drug Administration — a criminal organization that’s working hard to do what every criminal organization does: Eliminate the competition!As the defender of Big Pharma, the FDA is also the destroyer of knowledge that seeks to remove educational statements from the internet. Truth has nothing to do with it — it is verifiably true that anti-viral herbs, probiotics and other natural products help protect consumers from influenza — but the FDA cannot allow such statements to remain online for the simple fact that people might become informed. And that, it seems, would be a dangerous precedent.

If people were informed about the healing and protective powers of herbs, they would no longer remain enslaved by the medical establishment. Profits would be lost. Power would evaporate. This is why people can never be allowed to attain any real knowledge about herbs, superfoods or nutritional supplements. And the FDA will threaten people with imprisonment just to make sure they don’t dare publish knowledge that the FDA does not want the people to see.

Targeted by the FDA

Who is being attacked and threatened by the FDA? Lots of companies offering highly-effective natural remedies.

Byron Richards’ company Wellness Resources, a favorite target of the FDA (no doubt because Richards wrote a book attacking the FDA), is also targeted in this censorshipcampaign.

The FDA sends similar letters to other companies, invoking terrorizing language designed to scare companies into self-censorship. This is the FDA’s key strategy, and it largely works: Most companies are scared to death to take a stand against the FDA because the ones that do end up being shut down, with their owners arrested at gunpoint and thrown in prison.

This is how natural medicine advocates are treated in the United States of America, the “land of the free and the home of the brave.” (It is really the land of the enslaved and the home of the cowards who don’t even have the courage to protest in the streets anymore…)

This is how the FDA secretly intimidates the natural products industry: It sends threatening letters to anyone who dares tell the truth about a natural product they sell. While pharmaceuticals can openly and brazenly lie about their supposed benefits, natural product companies aren’t even allowed to state obvious truths about their products! (Like “Vitamin C helps prevent colds” or “Omega-3 oils improve moods.”)

Note, carefully, that the FDA openly brands the people promoting natural anti-viral products as “criminals.” The language from the FDA’s own website says it is listing “Web sites that are illegally marketing unapproved, uncleared, or unauthorized products in relation to the 2009 H1N1 Flu Virus.”

In reality, this FDA list is a really good list of highly effective natural products that can protect you from Swine Flu. Many of the companies on the list, in fact, offer products that are far more effective than any vaccine or Big Pharma anti-viral drug. And that, by the way, is precisely why the FDA must accuse these companies of being criminals: Products that effectively compete with Big Pharma’s drugs simply cannot be allowed to exist in the marketplace!

This is all about destroying the competition, limiting consumer options and censoring truthful health information on the internet.

And it’s all paid for by your tax dollars, by the way. This is a government operation taking place under the Obama Administration, which apparently continues in the Bush Administration’s footsteps when it comes to destroying the natural products industry and leaving consumers helpless in the next great pandemic.

Click here to for the full story and links to vital information from NaturalNews.com